About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

General Description: 

BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals.  This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet the aggressive timelines. The individual will provide support to cross-functional teams on CMC regulatory strategies.

Essential Functions of the job:

Develop and implement small molecule/large molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications.Prepare CTD M2.3 in English/Japanese based on M3 from Global Reg CMC team.Prepare CTD M1.2 “Application Form” in English/Japanese based on CTD M2.3.Respond/prepare answer against inquiry from PMDA with Global Reg CMC.Evaluate CMC “Change Control” on Japan filing impact and guide/evaluate “PCA” or “MCN” with global RA CMC team.Manage manufacturing license including Foreign Manufacturer Accreditation (FMA) for Japan products.Together with global RA CMC team, develop Japan regulatory strategy and execute in the preparation of timely responses to small molecule/large molecule CMC regulatory questions, pre-meeting packages, and interactions with Japan Heath Authorities as needed for the assigned project.Work collaboratively with cross-functional leads and communicates Japan CMC regulatory strategies for the assigned projects.Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle for Japan related submissions. Escalate the critical issues to senior management timely.Lead or contribute to development of internal small molecule/large molecule CMC regulatory guidance and working instructions for Japan submissions.Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project in the Japan market.Provide CMC regulatory review for clinical protocols and investigator brochures, etc., for the assigned project related to Japan submissions.Provide comments on new global guidance through company’s commenting process.

Supervisory Responsibilities:  

The position may have opportunity to manage direct report.

Computer Skills:  

Microsoft 365, Word, Excel, Power Point, familiar with Veeva vault is a plus.

Qualification Required:

Education Required:  BA/BS Degree in sceintific disciplines, MS/PhD preferred

Other Qualifications:  

3+ years of related pharmaceutical or pharmaceutical industry regulatory CMC experience with proven record of experience in global submissions for clinical trial/market applications and subsequentresponse to HA queries.Experiences to prepare CTD M2.3 and M1.2 (Application Form).Experiences to respond against inquiries from PMDA.In-depth knowledge of ICH requirements, US/EU/JP regulatory and requirements.Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus.Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections.Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).Excellent oral and written communications skills are a must-have.The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment

Travel: 

0-5%  As needed

What We Offer To Our Valued Employees

Market competitive compensation package including performance-based annual bonus schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.Join us and Make momentum in your career!

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.